Spine Stereotactic Radiosurgery for Spinal Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Samuel T. Chao, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Hematologic malignancies, Multiple cancers, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Spine Stereotactic Radiosurgery for Spinal Cancer?

Research shows that stereotactic body radiotherapy (SBRT) is highly effective for treating spinal metastases, with improved pain relief and local control compared to traditional methods. A specific regimen of 24 Gy in 2 fractions has strong evidence for balancing effectiveness and minimizing side effects.

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Is Spine Stereotactic Radiosurgery (SRS) safe for humans?

Spine Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) are generally considered safe, but they do carry some risks. Studies have shown that while these treatments can effectively target spinal tumors, they may increase the risk of vertebral body fractures (breaks in the bones of the spine).

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How is Spine Stereotactic Radiosurgery (SRS) different from other treatments for spinal cancer?

Spine Stereotactic Radiosurgery (SRS) is unique because it delivers high-dose radiation precisely to spinal tumors in one or two sessions, minimizing damage to surrounding healthy tissue. This advanced technique is particularly beneficial for treating tumors near the spinal cord, where conventional radiation might not be feasible due to the risk of damaging the spinal cord.

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Eligibility Criteria

This trial is for individuals with cancer that has spread to their spine, affecting up to three separate sites without causing spinal cord compression. Participants must be in good physical condition (KPS ≥ 70), able to undergo MRI scans, and not pregnant. Those who've had prior radiation at the index site may join, but not if they've had specific spine treatments or have certain types of cancer like lymphoma.

Inclusion Criteria

Negative pregnancy test within four weeks of registration for women of childbearing potential.

My overall health status fits within a specific range and my cancer is either controlled or not, depending on other health factors.

History and physical within four weeks of registration.

Exclusion Criteria

You have an ongoing connective tissue disease that is currently active.

My cancer has spread to more than 5 levels of my spine.

I have a spinal cord compression that needs urgent care.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spine stereotactic radiosurgery (sSRS) in either one or two sessions depending on the assigned group

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for vertebral compression fractures, quality of life, local control, pain control, and toxicity

12 months

Follow-up MRIs at 1 month, 3 months, 6 months, and 12 months

Participant Groups

The study compares single-session versus two-session Spine Stereotactic Radiosurgery (sSRS) for treating vertebral metastases. It aims to determine which method better prevents vertebral compression fractures after delivering high-dose x-ray treatments focused on the affected areas of the spine.

Group I: Arm 1 - Single fraction Experimental Treatment 6 Interventions

sSRS 18 Gy in 1 fraction

Group II: Arm 2 - Two fraction Active Control 6 Interventions

sSRS 24 Gy in 2 fractions

Spine SRS in 1 fraction is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Spine Stereotactic Radiosurgery for:

• Vertebral metastases
• Spinal tumors
• Pain relief
• Neurological symptoms

🇪🇺 Approved in European Union as Spine Radiosurgery for:

• Vertebral metastases
• Spinal tumors
• Pain relief
• Neurological symptoms

🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy (SBRT) for:

• Vertebral metastases
• Spinal tumors
• Pain relief
• Neurological symptoms

🇯🇵 Approved in Japan as Spine Stereotactic Radiosurgery for:

• Vertebral metastases
• Spinal tumors
• Pain relief
• Neurological symptoms

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center Cleveland, OH

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy: an emerging treatment for spinal metastases. [2019] The purpose of this concise update is to describe the emerging treatment of stereotactic body radiotherapy (SBRT) for spinal metastases.

2. China pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy as a primary treatment for spinal metastasis: a single institution experience. [2021] To investigate the clinical outcome including efficacy and safety of stereotactic body radiotherapy (SBRT) in management of spinal metastasis.

3. England pubmed.ncbi.nlm.nih.gov

Surgical resection of epidural disease improves local control following postoperative spine stereotactic body radiotherapy. [2022] Spine stereotactic body radiotherapy (SBRT) is increasingly being applied to the postoperative spine metastases patient. Our aim was to identify clinical and dosimetric predictors of local control (LC) and survival.

4. United States pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023] Stereotactic body radiotherapy (SBRT) has proven to be a highly effective treatment for selected patients with spinal metastases. Randomized evidence shows improvements in complete pain response rates and local control with lower retreatment rates favoring SBRT, compared to conventional external beam radiotherapy (cEBRT). While there are several reported dose-fractionation schemes for spine SBRT, 24 Gy in 2 fractions has emerged with Level 1 evidence providing an excellent balance between minimizing treatment toxicity while respecting patient convenience and financial strain.

5. United States pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation for the spine: a review. [2013] Stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) for spinal metastases are emerging treatment paradigms in the multidisciplinary management of metastases located within or adjacent (paraspinal) to the vertebral bodies/spinal cord. In this review, we provide a brief overview of spine SBRT/SRS indications, technology, planning, and treatment delivery; review the current state of the literature; and discuss the radiobiology, toxicity, and limitations of SBRT/SRS for metastatic disease of the spine.

6. United States pubmed.ncbi.nlm.nih.gov

Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. [2021] Paraspinal stereotactic body radiotherapy (SBRT) involves risks of severe complications. We evaluated the safety of the paraspinal SBRT program in a large academic hospital by applying failure modes and effects analysis.

7. United States pubmed.ncbi.nlm.nih.gov

Vertebral body fracture rates after stereotactic body radiation therapy compared with external-beam radiation therapy for metastatic spine tumors. [2023] Stereotactic body radiation therapy (SBRT) is utilized to deliver highly conformal, dose-escalated radiation to a target while sparing surrounding normal structures. Spinal SBRT can allow for durable local control and palliation of disease while minimizing the risk of damage to the spinal cord; however, spinal SBRT has been associated with an increased risk of vertebral body fractures. This study sought to compare the fracture rates between SBRT and conventionally fractionated external-beam radiation therapy (EBRT) in patients with metastatic spine tumors.

8. England pubmed.ncbi.nlm.nih.gov

The role of stereotactic body radiotherapy and stereotactic radiosurgery in the re-irradiation of metastatic spinal tumors. [2014] Stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) are advanced radiotherapy delivery techniques that allow for the delivery of high-dose per fraction radiation. Advances in imaging technology and intensity modulation have allowed SRS and SBRT to be used for the treatment of tumors in close proximity to the spinal cord and cauda equina, in particular spinal metastases. While the initial treatment of spinal metastases is often conventional palliative radiotherapy, treatment failure is not uncommon, and conventional re-irradiation may not be feasible due to spinal cord tolerance. SBRT and SRS have emerged as important techniques for the treatment of spinal metastases in the proximity of previously irradiated spinal cord. Here we review the current data on the use of SBRT and SRS spinal re-irradiation, and future directions for these important treatment modalities.

9. England pubmed.ncbi.nlm.nih.gov

Spine radiosurgery for spinal metastases: indications, technique and outcome. [2014] Early diagnosis, better imaging, and advanced treatment of cancer patients extend survival and increase the incidence of symptomatic spine metastases. The treatment algorithm for spine metastases has shifted to a more aggressive approach in recent years. Spine stereotactic radiosurgery (SRS) is a relatively new tool utilizing advanced imaging systems, planning software, image-guided localization, and intensity-modulated dose delivery. Radiosurgery of spine metastases yields high rates of pain- and tumor control, and offers both the patients and the treating physicians an effective noninvasive alternative. This review presents the indications and outcomes for SRS and describes current techniques.